Acceptance-based Intervention at Colorectal Cancer Patients (ABICOL)

National and Kapodistrian University of Athens

Status: Unknown

Conditions: Colorectal Neoplasms; Acceptance Process; Pain, Procedural

Treatments: Behavioral: ACCEPTANCE-BASED INTERVENTION

Study type: Interventional

Funder types: Other

Identifiers

NCT04573088

IRB6/26-2-2019

Details and patient eligibility

About

Taking into account the unavoidable effect of a major oncologic surgery commonly required for colorectal cancer patients and the recognized psychological and functional sequelae of the surgical treatment on their status, we will evaluate the influence of a psychological intervention, known as acceptance-based intervention, offered to those patients at the preoperative setting. Reduction of anxiety and assessmemt of indices of post-intervention psychological and functional recovery will be the primary goals of the study.

Full description

Introduction: Uncertainty, fears and anxiety are common reactions to an upcoming colectomy for colorectal cancer patients and are related not only to cancer disease, but also to the inevitable change in colon anatomy, affecting their preoperative psychological and functional condition and their postsurgical recovery.

Purpose: We aim to evaluate the psychological and functional recovery of colorectal cancer patients, who undergo colectomy, after an acceptance-based nursing intervention. The scope of this brief preoperative intervention is to enable patients to cope more efficiently with the upcoming surgery and their health status, as it is expected to reduce anxiety and have positive effect on postsurgical psychological and functional recovery.

Methods: The study includes histologically diagnosed patients with colorectal cancer, regardless of stage, who are scheduled to undergo colectomy. Patients will be divided into two groups-the experimental and the control group-by simple randomization. Both groups are going to complete a set of same questionnaires regarding quality of life, sleep, anxiety, depression and functional status. Patients in the control arm will then receive treatment-as-usual while patients in the experimental arm will also receive an acceptance-based intervention before surgery. Postoperatively, for both groups, apart from the self-reported symptoms, we will assess objective recovery factors, such as postoperative complications

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with histologically proven colorectal adenocarcinoma
• Age > 18 years

Exclusion criteria

• Metastasis at time of diagnosis
• Recurrence at time of diagnosis
• History of other malignancies
• Mental retardation
• Deafness
• Illiteracy
• ASA score>3
• Poor performance status

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

ABICOL

Experimental group

Description:

24 hours prior to surgery the patients undergo acceptance-based intervention, incorporating questions about their subjective perception about the surgery, the domains of their lives that have been affected, and on their own expectations from surgery and its effects on their lives. They will be asked to express their fears and worries about their condition and they will be discussed about the likelihood of experiencing postoperative pain.

Treatment:

Behavioral: ACCEPTANCE-BASED INTERVENTION

CONTROL

No Intervention group

Description:

No acceptance-based intervention or other discussion related to the patients' fears and worries will be applied.